The present invention relates to a coupling device for coupling a vial connector to a drug vial. The invention can be implemented for aseptic preparation and handling of drugs involving a special vial connector having a cannula which is utilised for puncturing the seal of a drug vial or another drug bottle.
When preparing drugs, intended for e.g. injection or infusion, demands are made on aseptic conditions. In order to achieve such conditions when preparing drugs, for example in hospitals and pharmacies, special safety boxes or cabinets in a clean room environment normally are utilised.
Recently, a serious problem in connection with drug preparation and other similar handling has been observed. It has been found that medical and pharmacological staff can be exposed to drugs or solvents in the ambient air while performing drug preparation. This problem is particularly serious when the preparation of e.g. cytotoxic drugs is concerned. Cytotoxic drugs have been reported to constitute a working environment problem when they escape into the environment. Antiviral drugs, antibiotics and radiopharmaceuticals are other drugs which can create working environment problems.
Therefore, it has been proposed that aseptic preparation and handling of drugs should be accomplished by means of special assemblies which are sealed against the ambient air before and during administration to a patient.
Accordingly, U.S. Pat. No. 5,766,147 discloses a device which provides for direct incorporation of a substance from a separate container, such as a drug vial, into the contents of a liquid delivery device, which has a connecter to provide communication between the device and the container, and means for closing the connection prior to dispensing the contents of the device. Furthermore, U.S. Pat. No. 5,766,147 discloses a method for permitting a substance in a container to be transferred to a liquid delivery device, and the contents of the device to be administrated to a patient.
Furthermore, WO 98/32411 discloses a luer connector comprising a luer connectable to a syringe and which extends to a sharpened end capable of being driven through a puncturable vial closure to thereby puncture the closure, a luer support which is mountable on a vial and which initially supports the luer in a first position in which the sharpened end of the conduit is pointed towards the closure. The luer connector further comprises a luer driver such that movement of the driver relative to the support causes the luer to be driven so that the sharpened end punctures the closure and enters the vial. The luer connector facilitates connection of a hypodermic syringe to the vial.
The patent publication FR 2 714 824 discloses a vial device comprising an external cover exhibiting a first, open end and a second, closed end provided with a passage for a liquid. The cover comprises perforating means in which the perforating end projects through the passage into the cover. The perforating means exhibits an internal channel which extends the passage. Thereby, a vial exhibits a body having a a first end provided with puncturable membrane and a second end sealed by a piston slidingly mounted within the body of the vial. When in a storage position, the vial is coupled to the cover and is arranged to be pressed into the cover in such a way that the perforating means punctures the deformable membrane, with sealing means between the cover and the body of the vial.
Many drugs are provided in a dry form in order to achieve a longer shelf life, e.g. so-called lyophilized drugs. Such drugs have to be prepared by means of adding a suitable solvent before being administrated to a patient. This is usually accomplished by means of a special connector assembly or the like for enabling attachment of the vial to a source of solvent to reconstitute the dry drug.
Accordingly, EP 0 829 250 A2 discloses a connector assembly for efficient flow of liquid into and/or out of a vial, such as a vial containing a lyophilized drug. The connector assembly features a collar which is mountable to the rim of the vial in a locked position and thereafter removable by an end-user when disposal of the device is desired.
Thus, aseptic preparation and handling of drugs often involve that a special connector having a cannula is utilized for puncturing the seal or closure of a drug vial or drug bottle. The previously known methods for coupling such connectors to a vial and puncturing the seal of the vial are associated with certain problems.
For instance, it has been found that the cannula of the vial connector often may puncture the vial seal in an undesirable way, e.g. so that the cannula creates a larger perforation in the vial seal than necessary, and thereby increases the risk that cytotoxic drugs or the like escape into the working environment.
In cases where the previously known vial connectors are pressed down manually around the neck of a drug vial, it can be difficult to obtain a sufficient force in order to obtain a secure locking of the connector around the neck of the vial.
Furthermore, the previously known assemblies for coupling a connector to the neck of a vial or bottle can only accommodate drug vials or bottles of one single predetermined size. In view of the above described deficiencies associated with previously known assemblies and methods for coupling a connector to the neck of a vial or bottle, the present invention has been developed. These enhancements and benefits are described in greater detail hereinbelow with respect to several alternative embodiments of the present invention.
The present invention in its several disclosed embodiments alleviates the drawbacks described above with respect to conventional assemblies and methods for coupling a connector to the neck of a vial or bottle and incorporates several additionally beneficial features.
Accordingly, a first object of the present invention is to provide a coupling device for coupling a vial connector to a drug vial which eliminates the above-mentioned problems associated with known devices and methods. Furthermore, arrangements configured according to the present invention ensure that vial connectors of different sizes can be coupled to drug vials or bottles of different sizes in a way preventing the cannula of the vial connector from creating a larger hole than necessary in the seal of the drug vial, while ensuring that the vial connector is pressed down over the neck of the vial with a force sufficient for achieving a permanent coupling of the vial connector to the drug vial.
This first object of the present invention is achieved by means of the coupling device comprising first positioning means for holding the drug vial in a first position, and further comprising second positioning means for holding the vial connector in a second position. The coupling device further comprises actuating means for bringing the drug vial and/or the vial connector into a third position in which the cannula penetrates the seal in a direction along an axis substantially perpendicular to a main plane of the seal. According to the invention, the coupling device comprises guiding means controlling the direction, wherein the actuating means are designed for applying a force in the above-mentioned direction on the drug vial and/or the vial connector enabling the locking means to become permanently locked around the neck when reaching the third position. Thereby, the first positioning means are adjustable for holding drug vials of several different dimensions and/or the second positioning means are adjustable for holding vial connectors of several different dimensions. Furthermore, the coupling device is designed for allowing the first and second positioning means to release the vial and the vial connector after having reached the third position.
Further objects of the present invention will become evident from the following description, while the features enabling the further objects to be reached are defined in the dependent claims.
The beneficial effects described above apply generally to each of the exemplary devices and methods disclosed herein as they relate to coupling a connector to the neck of a vial or bottle. The specific structures and steps through which these benefits are delivered will be described in detail hereinbelow.